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PubMed2000

A randomized controlled study of reviewer bias against an unconventional therapy.

A study was designed to test the hypothesis that experts who review papers for publication are prejudiced against an unconventional form of therapy. Two versions were produced (A and B) of a 'short report' that related to treatments of obesity, identical except for the nature of the intervention. Version A related to an orthodox treatment, version B to an unconventional treatment. 398 reviewers were randomized to receive one or the other version for peer review. The primary outcomes were the reviewers' rating of 'importance' on a scale of 1-5 and their verdict regarding rejection or acceptance of the paper. Reviewers were unaware that they were taking part in a study. The overall response rate was 41.7%, and 141 assessment forms were suitable for statistical evaluation. After dichotomization of the rating scale, a significant difference in favour of the orthodox version with an odds ratio of 3.01 (95% confidence interval, 1.03 to 8.25), was found. This observation mirrored that of the visual analogue scale for which the respective medians and interquartile ranges were 67% (51% to 78.5%) for version A and 57% (29.7% to 72.6%) for version B. Reviewers showed a wide range of responses to both versions of the paper, with a significant bias in favour of the orthodox version. Authors of technically good unconventional papers may therefore be at a disadvantage in the peer review process. Yet the effect is probably too small to preclude publication of their work in peer-reviewed orthodox journals.

Bias↗

PubMed1982

Peer review of psychodynamic psychotherapy. Experimental studies of the American Psychological Association/CHAMPUS program.

Two factorial experiments examined the effects of reviewer theoretical orientation, documented treatment progress, and patient concurrence data on the peer review of clinical treatment reports that described long-term psychodynamic psychotherapy with a depressed, female outpatient. The experiments employed an unobtrusive methodology; peer reviewers believed that their evaluations would affect the disposition of actual mental health insurance claims. Subjects (n = 105) were American Psychological Association/Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) peer reviewers of a psychodynamic, behavioral, or eclectic theoretical orientation. The psychodynamic reviewers, compared with the behavioral and eclectic reviewers, were more positive in their ratings of treatment and more generous in their future care reimbursement recommendations. Additionally, the data demonstrated that APA/CHAMPUS peer review was sensitive to reported treatment progress, and that reviewers of diverse orientations were equally responsive to documented progress in psychodynamic psychotherapy. The patient concurrence manipulation had little effect on the dependent measures. Implications for mental health quality assurance programs are discussed.

Health Benefit Plans, Employee↗

PubMedDate not supplied

Peer review in carcinogenicity bioassays: uses/abuses.

"Truth is the essence of science," and "peer review" is a key element in assuring the "truth". Peer review is particularly important with regard to diagnostic pathology in bioassays used for regulatory purposes and approval of drugs and medical devices for at least 2 reasons: (a) If a study is designed correctly and conducted properly, the bottom-line results rely almost entirely on pathological interpretations, and (b) diagnostic pathology is a subjective science that relies on the training and experience of the pathologist and therefore is subject to individual bias. "Bias" can be introduced during the collection and preparation of pathological materials, use of inconsistent terminology during the pathology evaluation and interpretation of the results. Peer review can help in reducing this bias. However, peer review is also subject to bias by knowledge of treatment groups, selection of inappropriate slides for review, in the type of question asked of the reviewers, and in the selection of the reviewers. When done correctly, pathology peer review can be an effective and important part of a process to assure the results of a study, but when done improperly it can cloud the issue and have a negative impact on the credibility of the study.

Animals↗

PubMedDate not supplied

Blind versus nonblind review: survey of selected medical journals.

The publication of scientific research in medical journals is a lengthy process. Submitted manuscripts are often reviewed by two or more outside reviewers who evaluate each manuscript for publication acceptability. The process of manuscript evaluation by an editor-selected reviewer ("peers" or "referees") is termed "peer review." One issue involving the peer-review process is the use of blind versus nonblind referees. The purpose of this survey was to determine the percentage of a select group of medicine-related journals that blind their reviewers. We surveyed 114 English language journals. Journal editors were sent a survey that asked two questions: (1) are the referees who review your manuscripts blinded to the identity of the authors? and (2) is the editor blinded to the identity of the authors until after the review of the manuscripts is complete? Ninety-six of 114 (84.2 percent) surveys were returned. Ten journals published invited manuscripts only and were excluded from the survey. Only 18.6 percent (16 of 86) of the journals currently blind referees. None of the journals' editors were blind to the identity of the manuscripts' authors.

Medicine↗

PubMed2001

Updating a systematic review--what difference did it make? Case study of nicotine replacement therapy.

AIMS: To examine the effect of updating a systematic review of nicotine replacement therapy on its contents and conclusions. METHODS: We examined the effects of regular updating of a systematic review of nicotine replacement therapy for smoking cessation. We considered two outcomes. First, we assessed the effect of adding new data to meta-analyses, comparing results in 2000 with the results in 1994. Second, we assessed qualitatively the ways in which the nature of the questions addressed by the review had changed between the two dates. For the first outcome, we compared the number of trials, the pooled estimate of effect using the odds ratio, and the results of pre-specified subgroup analyses, for nicotine gum and patch separately. Using a test for interaction, we assessed whether differences between estimates were statistically significant. RESULTS: There were ten new trials of nicotine gum between 1994 and 2000, and the meta-analytic effect changed little. For the nicotine patch the number of trials increased from 9 to 30, and the meta-analytic effect fell from 2.07 (95% CI 1.64 - 2.62) to 1.73 (95% CI 1.56 - 1.93). Apparent differences in relative effect in sub-groups found in 1994 were not found in 2000. The updated systematic review addressed a number of questions not identified in the original version. CONCLUSIONS: Updating the meta-analyses lead to a more precise estimate of the likely effect of the nicotine patch, but the clinical message was unchanged. Further placebo controlled NRT trials are not likely to add to the evidence base. It is questionable whether updating the meta-analyses to include them is worthwhile. The content of the systematic review has, however, changed, with the addition of data addressing questions not considered in the original review. There is a tension between the principle of identifying the important questions prior to conducting a review, and keeping the review up to date as primary research identifies new avenues of enquiry.

Humans↗

PubMed2005

Evidence of the efficacy of occupational therapy in different conditions: an overview of systematic reviews.

OBJECTIVE: To summarize the research evidence available from systematic reviews of the efficacy of occupational therapy (OT) for practitioners, researchers, purchasing organizations and policy-makers. DATA SOURCE: The search for systematic reviews was conducted in PubMed and the Cochrane Library (October 2004). METHODS: The reviews included were those that utilized a systematic search for evidence with regard to OT for specific patient groups. Data were summarized for patient group, interventions, outcome domains, type of study designs included, method of data synthesis and conclusions. RESULTS: Fourteen systematic reviews were included. Three reviews related to rheumatoid arthritis, four reviewed stroke and four focused on elderly people. Reviews of Parkinson's disease, multiple sclerosis, Huntington's disease, cerebral palsy and mental illnesses were also identified. The reviews of rheumatoid arthritis, stroke and elderly people showed evidence of the efficacy of OT in increasing functional abilities. Positive results were presented for quality of life and social participation in elderly people and stroke respectively. The efficacy of OT in all other patient groups is unknown due to insufficient evidence. CONCLUSION: This summary shows that elderly people and people with stroke or rheumatoid arthritis can expect to benefit from comprehensive OT. Evidence of the efficacy of specific interventions is sparse and should be addressed in future research. The evidence that does exist should be incorporated into OT practice.

Aged↗

PubMed2005

Reducing workload in systematic review preparation using automated citation classification.

OBJECTIVE: To determine whether automated classification of document citations can be useful in reducing the time spent by experts reviewing journal articles for inclusion in updating systematic reviews of drug class efficacy for treatment of disease. DESIGN: A test collection was built using the annotated reference files from 15 systematic drug class reviews. A voting perceptron-based automated citation classification system was constructed to classify each article as containing high-quality, drug class-specific evidence or not. Cross-validation experiments were performed to evaluate performance. MEASUREMENTS: Precision, recall, and F-measure were evaluated at a range of sample weightings. Work saved over sampling at 95% recall was used as the measure of value to the review process. RESULTS: A reduction in the number of articles needing manual review was found for 11 of the 15 drug review topics studied. For three of the topics, the reduction was 50% or greater. CONCLUSION: Automated document citation classification could be a useful tool in maintaining systematic reviews of the efficacy of drug therapy. Further work is needed to refine the classification system and determine the best manner to integrate the system into the production of systematic reviews.

Artificial Intelligence↗

PubMed2005

[Diversity and frequency of scientific research design and statistical methods in the "Arquivos Brasileiros de Oftalmologia": a systematic review of the "Arquivos Brasileiros de Oftalmologia"--1993-2002].

PURPOSE: To verify the frequency of study design, applied statistical analysis and approval by institutional review offices (Ethics Committee) of articles published in the "Arquivos Brasileiros de Oftalmologia" during a 10-year interval, with later comparative and critical analysis by some of the main international journals in the field of Ophthalmology. METHODS: Systematic review without metanalysis was performed. Scientific papers published in the "Arquivos Brasileiros de Oftalmologia" between January 1993 and December 2002 were reviewed by two independent reviewers and classified according to the applied study design, statistical analysis and approval by the institutional review offices. To categorize those variables, a descriptive statistical analysis was used. RESULTS: After applying inclusion and exclusion criteria, 584 articles for evaluation of statistical analysis and, 725 articles for evaluation of study design were reviewed. Contingency table (23.10%) was the most frequently applied statistical method, followed by non-parametric tests (18.19%), Student's t test (12.65%), central tendency measures (10.60%) and analysis of variance (9.81%). Of 584 reviewed articles, 291 (49.82%) presented no statistical analysis. Observational case series (26.48%) was the most frequently used type of study design, followed by interventional case series (18.48%), observational case description (13.37%), non-random clinical study (8.96%) and experimental study (8.55%). CONCLUSION: We found a higher frequency of observational clinical studies, lack of statistical analysis in almost half of the published papers. Increase in studies with approval by institutional review Ethics Committee was noted since it became mandatory in 1996.

Bibliometrics↗

PubMed2004

Peer-review and publication of research protocols and proposals: a role for open access journals.

Peer-review and publication of research protocols offer several advantages to all parties involved. Among these are the following opportunities for authors: external expert opinion on the methods, demonstration to funding agencies of prior expert review of the protocol, proof of priority of ideas and methods, and solicitation of potential collaborators. We think that review and publication of protocols is an important role for Open Access journals. Because of their electronic form, openness for readers, and author-pays business model, they are better suited than traditional journals to ensure the sustainability and quality of protocol reviews and publications. In this editorial, we describe the workflow for investigators in eHealth research, from protocol submission to a funding agency, to protocol review and (optionally) publication at JMIR, to registration of trials at the International eHealth Study Registry (IESR), and to publication of the report. One innovation at JMIR is that protocol peer reviewers will be paid a honorarium, which will be drawn partly from a new submission fee for protocol reviews. Separating the article processing fee into a submission and a publishing fee will allow authors to opt for "peer-review only" (without subsequent publication) at reduced costs, if they wish to await a funding decision or for other reasons decide not to make the protocol public.

Access to Information↗

PubMed2005

A case study of a retracted systematic review on interactive health communication applications: impact on media, scientists, and patients.

BACKGROUND: In October 2004, a flawed systematic review entitled "Interactive Health Communication Applications for People with Chronic Disease" was published in the Cochrane Library, accompanied by several press releases in which authors warned the public of the negative health consequences of interactive health communication applications, including the Internet. Within days of the review's publication, scientists identified major coding errors and other methodological problems that invalidated the principal conclusions of the study and led to a retraction. While the original study results and their negative conclusions were widely publicized in the media, the retraction seemed to go unnoticed. OBJECTIVE: This paper aims to document an unprecedented case of misinformation from a Cochrane review and its impact on media, scientists, and patients. As well, it aims to identify the generic factors leading to the incident and suggest remedies. METHODS: This was a qualitative study of the events leading to the retraction of the publication and of the reactions from media, scientists, and patients. This includes a review and content analysis of academic and mass media articles responding to the publication and retraction. Mass media articles were retrieved in May 2005 from LexisNexis Academic and Google and were classified and tallied. The extended case method is employed, and the analysis is also applied to comparable publishing events. RESULTS: A search on LexisNexis Academic database with the query "Elizabeth Murray AND health" for the period of June 2004 to May 2005 revealed a total of 15 press reports, of which only 1 addressed the retraction. Google was searched for references to the review, and the first 200 retrieved hits were analyzed. Of these, 170 pages were not related to the review. Of the remaining 30 pages, 23 (77%) were reports about the original publication that did not mention the retraction, 1 (3%) was a bibliography not mentioning the retraction, and 6 (20%) addressed the retraction, of which only 1 was a non-Cochrane-related source. CONCLUSIONS: Analyzed retrievals showed that the mass media gave more coverage to the Cochrane review than to the retraction or to a related systematic review with a similar scope but a different conclusion. Questionable results were prematurely disseminated, oversimplified, and sensationalized, while the retraction was hardly noticed by the public. Open commentary by scientists and patients helped to rapidly identify the errors but did not prevent or correct the dissemination of misinformation.

Humans↗

PubMed1996

Group peer review: a questionnaire-based survey.

OBJECTIVE: This paper presents the findings from a questionnaire-based survey of psychiatrists designed to elucidate the positive and negative aspects of group peer review and its perceived place in accountability procedures, and to provide information about how accountability through group peer review might be improved. METHOD: Three hundred and eighty-eight psychiatrists were surveyed via mailout questionnaire. Demographic data, details of groups, and perceptions of beneficial and detrimental effects of group peer review were sought from group participants and non-participants. Attitudes of participants were compared with those of non-participants. Features of groups related to satisfaction in participants were examined. RESULTS: The majority of the 170 respondents participating in groups regarded peer review as a means of maintaining and improving skills, sharing ideas and methods, receiving constructive criticism and feedback, of educational benefit and an important source of professional accountability. Non-participants, while less positive overall, responded equally that participation in peer review groups would be an effective response to accountability procedures. Potential detrimental effects and problems with the functioning of peer review groups were elucidated. CONCLUSIONS: Group peer review contributes significantly to professional accountability and education in well-functioning groups. Further strategies for the facilitation of group functioning and for the processing of problems arising in group peer review need to be developed to optimise its contribution to the maintenance and improvement of professional standards.

Adolescent Psychiatry↗

PubMed2006

Clinical effectiveness and cost-effectiveness of laparoscopic surgery for colorectal cancer: systematic reviews and economic evaluation.

OBJECTIVE: The aim of this study was to determine the clinical effectiveness and cost-effectiveness of laparoscopic, laparoscopically assisted (hereafter together described as laparoscopic surgery) and hand-assisted laparoscopic surgery (HALS) in comparison with open surgery for the treatment of colorectal cancer. DATA SOURCES: Electronic databases were searched from 2000 to May 2005. A review of economic evaluations was undertaken by the National Institute for Health and Clinical Excellence in 2001. This review was updated from 2000 until July 2005. REVIEW METHODS: Data from selected studies were extracted and assessed. Dichotomous outcome data from individual trials were combined using the relative risk method and continuous outcomes were combined using the Mantel-Haenszel weighted mean difference method. Summaries of the results from individual patient data (IPD) meta-analyses were also presented. An economic evaluation was also carried out using a Markov model incorporating the data from the systematic review. The results were first presented as a balance sheet for comparison of the surgical techniques. It was then used to estimate cost-effectiveness measured in terms of incremental cost per life-year gained and incremental cost per quality-adjusted life-year (QALY) for a time horizon up to 25 years. RESULTS: Forty-six reports on 20 studies [19 randomised controlled trials (RCTs) and one IPD meta-analysis] were included in the review of clinical effectiveness. The RCTs were of generally moderate quality with the number of participants varying between 16 and 1082, with 10 having less than 100 participants. The total numbers of trial participants who underwent laparoscopic or open surgery were 2429 and 2139, respectively. A systematic review of four papers suggested that laparoscopic surgery is more costly than open surgery. However, the data they provided on effectiveness was poorer than the evidence from the review of effectiveness. The estimates from the systematic review of clinical effectiveness were incorporated into a Markov model used to estimate cost-effectiveness for a time horizon of up to 25 years. In terms of incremental cost per life-year, laparoscopic surgery was found to be more costly and no more effective than open surgery. With respect to incremental cost per QALY, few data were available to differentiate between laparoscopic and open surgery. The results of the base-case analysis indicate that there is an approximately 40% chance that laparoscopic surgery is the more cost-effective intervention at a threshold willingness to pay for a QALY of pound 30,000. A second analysis assuming equal mortality and disease-free survival found that there was an approximately 50% likelihood at a similar threshold value. Broadly similar results were found in the sensitivity analyses. A threshold analysis was performed to investigate the magnitude of QALY gain associated with quicker recovery following laparoscopic surgery required to provide an incremental cost per QALY of pound 30,000. The implied number of additional QALYs required would be 0.009-0.010 compared with open surgery. CONCLUSIONS: Laparoscopic resection is associated with a quicker recovery (shorter time to return to usual activities and length of hospitalisation) and no evidence of a difference in mortality or disease-free survival up to 3 years following surgery. However, operation times are longer and a significant number of procedures initiated laparoscopically may need to be converted to open surgery. The rate of conversion may be dependent on experience in terms of both patient selection and performing the technique. Laparoscopic resection appears more costly to the health service than open resection, with an estimated extra total cost of between pound 250 and pound 300 per patient. In terms of relative cost-effectiveness, laparoscopic resection is associated with a modest additional cost, short-term benefits associated with more rapid recovery and similar long-term outcomes in terms of survival and cure rates up to 3 years. Assuming equivalence of long-term outcomes, a judgement is required as to whether the benefits associated with earlier recovery are worth this extra cost. The long-term follow-up of the RCT cohorts would be very useful further research and ideally these data should be incorporated into a wider IPD meta-analysis. Data on the long-term complications of surgery such as incisional hernias and differences in outcomes such as persisting pain would also be valuable. Once available, further data on both costs and utilities should be included in an updated model. At this point, further consideration should then be given as to whether additional data should be collected within ongoing trials. Few data were available to assess the relative merits of HALS. Ideally, there should be more data from methodologically sound RCTs. Further research is needed on whether the balance of advantages and disadvantages of laparoscopic surgery varies within subgroups based on the different stages and locations of disease. Research relating to the effect of experience on performance is also required.

Colorectal Neoplasms↗

PubMed2001

A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention.

BACKGROUND: Most surgically sutured wounds heal without any complication. However, in some cases wound healing can be delayed due to the presence of infection or wound breakdown. This can result in the wounds becoming cavity wounds and thus necessitate healing by secondary intention. Other surgical wounds that are not sutured but left to heal by secondary intention include abscess cavities such as perianal abscesses or breast abscesses. Surgical wounds healing by secondary intention are thought to heal more slowly than wounds healing by primary intention, especially if infection is present or healing is compromised by factors such as decreased blood supply, poor nutritional status or a general suppression of the immune response. Such wounds may contain dead tissue and have a moderate or high level of exudate. Debridement involves the removal of devitalised, necrotic tissue or fibrin from a wound. There are many different methods that can be used to debride a wound, which are broadly classified as surgical/sharp, biosurgical, mechanical, chemical, enzymatic and autolytic. Although it is generally agreed that the management of surgical wounds which contain devitalised tissue and are healing by secondary intention requires debridement, it is not always clear as to what is the best method or agent to use. There is currently a large selection of products with debriding properties available on the market, which vary considerably in cost. It is important that the choice of both debriding method and product is based on the best scientific evidence available, taking into account both cost and effectiveness data. OBJECTIVES: The review had two main objectives: (1) To determine the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. (2) To evaluate the clinical effectiveness and cost-effectiveness of treating patients with surgical wounds healing by secondary intention at specialised wound care clinics as compared to conventional care. The review incorporated all debriding methods and any agent that is considered to have a debriding property. METHODS The following databases were searched using strategies designed specifically for each database: MEDLINE, EMBASE, CINAHL, HMIC (Health Management Information Consortium), CCTR via the Cochrane Library, the National Research Register (NRR), the NHS Economic Evaluation Database (NHS EED), and the Health Economic Evaluations Database (HEED). Additional references were identified through reviewing manufacturer and sponsor submissions made to NICE, the bibliographies of retrieved articles, and conferences proceedings on the Internet. Only randomised controlled trials (RCTs) or non-randomised controlled trials with concurrent controls and full economic evaluations were considered for inclusion. Only studies that evaluated some sort of debriding method or a specialised wound care clinic (a nurse with specialist training in wound care; care being provided by a multidisciplinary team; a fast-track referral system to other professions (e.g. dermatologist); or access to the latest health technology) were included in the review. Studies had to include participants with surgical wounds healing by secondary intention (e.g. cavity wounds, the consequences of wound dehiscence and abscesses) and report an objective measure of wound healing. Data were extracted by one reviewer and checked by a second. Quality assessment was conducted independently by two reviewers. Disagreements were resolved by consensus and, when necessary, by recourse to a third reviewer. The primary outcomes of interest were wound healing and cost. Results of data extraction and quality assessment were presented in structured tables and also as a narrative summary. In addition, where feasible, the results of individual studies were presented as forest plots. Studies were grouped according to the type of wound, debriding method and outcome measure used. RESULTS - CLINICAL EFFECTIVENESS: Seventeen trials met the inclusion criteria, all of which used the autolytic method of debridement. No studies were found that investigated sharp/surgical, biosurgical, mechanical, chemical or enzymatic debridement in the treatment of surgical wounds healing by secondary intention. No studies were found which investigated specialised wound care clinics that included the provision of care within a clinical setting (based in either primary or secondary care). The type of surgical wounds investigated by studies included in the review were those that had broken down postoperatively, perineal wounds resulting from proctolectomy or rectal excision, and those left open after pilonidal sinus excision or abscess incision, or wounds following a laparotomy. Four additional studies investigated treatment of postoperative wounds from toenail avulsions. (ABSTRACT TRUNCATED)

Clinical Trials as Topic↗

PubMed2004

Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation.

OBJECTIVES: To review systematically the clinical effectiveness and the cost-effectiveness of clopidogrel used in combination with standard therapy including aspirin, compared with standard therapy alone for the treatment of non-ST-segment elevation acute coronary syndromes (ACS). DATA SOURCES: Electronic databases. Manufacturers' submissions. REVIEW METHODS: Studies were selected using rigorous criteria. The quality of randomised controlled trials (RCTs) was assessed according to criteria based on NHS CRD Report No. 4, and the quality of systematic reviews was assessed according to the guidelines for the Database of Reviews of Effect (DARE) criteria. The quality of economic evaluations was assessed according to a specifically tailored checklist. The clinical effectiveness and cost-effectiveness of clopidogrel in combination with standard therapy compared with standard therapy alone were synthesised through a narrative review with full tabulation of the results of the included studies. In the economic evaluations, a cost-effectiveness model was constructed using the best available evidence to determine cost-effectiveness in a UK setting. RESULTS: One RCT (the CURE trial) was a randomised, double-blind, placebo-controlled trial of high quality and showed that clopidogrel in addition to aspirin was significantly more effective than placebo plus aspirin in patients with non-ST-segment elevation ACS for the composite outcome of death from cardiovascular causes, non-fatal myocardial infarction or stroke over the 9-month treatment period. However, clopidogrel was associated with a significantly higher number of episodes of both major and minor bleeding. The results from the five systematic reviews that assessed the adverse events associated with long-term aspirin use showed that aspirin was associated with a significantly higher incidence of haemorrhagic stroke, extracranial haemorrhage and gastrointestinal haemorrhage compared with placebo. Of the cost-effectiveness evidence reviewed, only the manufacturer's submission was considered relevant from the perspective of the NHS. The review of this evidence highlighted potential limitations within the submission in its use of data and in the model structure used. These limitations led to the development of a new model with the aim of providing a more reliable estimate of the cost-effectiveness from the perspective of the UK NHS. This model indicated that clopidogrel appears cost-effective compared with standard care alone in patients with non-ST-elevation ACS as long as the NHS is willing to pay GBP6078 per quality of life year (QALY). The results were most sensitive to the inclusion of additional strategies that assessed alternative treatment durations with clopidogrel. Although treatment with clopidogrel for 12 months remained cost-effective for the overall cohort, provisional findings indicate that the shorter treatment durations may be more cost-effective in patients at low risk. CONCLUSIONS: The results of the CURE trial indicate that clopidogrel in combination with aspirin was significantly more effective than placebo combined with aspirin in a wide range of patients with ACS. This benefit was largely related to a reduction in Q-wave myocardial infarction. There was no statistically significant benefit in relation to mortality. The trial data suggested that a substantial part of the benefit derived from clopidogrel is achieved by 3 months, with a further small benefit over the remaining 9 months of chronic treatment. The results from the base-case model suggest that treatment with clopidogrel as an adjunct to standard therapy (including aspirin) for 12 months, compared with standard therapy alone, is cost-effective in non-ST elevation ACS patients as long as the health service is willing to pay GBP6078 per additional QALY. However, although treatment with clopidogrel for 12 months remained cost-effective for the overall cohort, provisional findings indicate that the shorter treatment durations may be more cost-effective in patients at low risk. To estimate the exact length of time that clopidogrel in addition to standard therapy should be prescribed for patients with non-ST-segment ACS would require a prospective trial that randomised patients to various durations of therapy. This would accurately assess whether a 'rebound' phenomenon occurs in patients if clopidogrel were stopped after 3 months of treatment.

Acute Disease↗

PubMed1988

A proposal for more informative abstracts of review articles.

This proposal presents guidelines for preparing informative abstracts of review articles. Six guidelines are proposed: 1. The abstract should begin with a precise statement of the primary objective of the review. 2. The data sources for the review should be succinctly summarized. 3. The criteria used to select studies from the data sources and the method by which these criteria were applied should be specified. 4. The guidelines used for abstracting data and assessing data quality should be described. 5. The main results of the review and the methods used to obtain these results should be stated. 6. Conclusions and potential applications of the review's results should be clearly and succinctly stated. Application of these guidelines can lead to efficient identification of relevant, scientifically sound review articles, a greater awareness of the vital elements of a good review article, more precise computerized literature searches, and improved peer-review processes.

Abstracting and Indexing↗

PubMed2006

Systematic review: smoking cessation intervention strategies for adults and adults in special populations.

BACKGROUND: While smoking cessation interventions have been shown to work, questions remain about how to increase their efficacy. PURPOSE: To examine strategies for effective tobacco treatment in adults and special populations. DATA SOURCES: MEDLINE, Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane Library, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts (1 January 1980 to 10 June 2005). STUDY SELECTION: Systematic reviews; randomized, controlled trials; and observational studies. DATA EXTRACTION: Two reviewers independently abstracted data on study design, population, sample size, treatment, outcomes, and quality. DATA SYNTHESIS: Findings from systematic reviews were summarized and compared with findings from original research published beyond date ranges included in the reviews. Strength of evidence was used to assess the body of evidence. Our review included studies evaluating the efficacy of cessation strategies, such as self-help, counseling, single pharmaceutical agents, combined pharmacotherapies, and pharmacotherapies combined with psychological counseling. Research findings consistent with previous reviews show that self-help strategies alone are ineffective, but counseling and pharmacotherapy used either alone or in combination can improve rates of success with quit attempts. Two studies of self-help materials reported discrepancies across effects. Five studies provided mixed results for counseling interventions. Fourteen studies provided sufficient evidence of the efficacy of single pharmacotherapy, combined pharmacotherapy, and psychological interventions either with or without pharmacotherapy. Few studies focused on ways to reach or treat special populations. Three studies with hospitalized patients had findings consistent with a previous review showing no strong evidence that clinical diagnosis affected the likelihood of quitting. New evidence was insufficient to address the effectiveness of interventions for persons with coexisting psychiatric conditions and substance abuse problems. LIMITATIONS: Previous systematic reviews variably cover the range of issues we addressed. More recent studies do not fill all gaps, especially those for persons with coexisting disease. CONCLUSIONS: Although self-help strategies alone marginally affect quit rates, individual and combined pharmacotherapies and counseling either alone or in combination can significantly increase cessation. Using effective smoking treatments is strongly encouraged for all populations, especially those with high and heavy rates of smoking, such as psychiatric and substance abuse populations.

Adolescent↗

PubMed1999

Epidermolysis bullosa of the head and neck: a case report of laryngotracheal involvement and 10-year review of cases at the Hospital for Sick Children.

OBJECTIVE: Epidermolysis bullosa (EB) involvement of the head and neck, particularly of the larynx, can represent a challenge to the otolaryngologist. In this article, we present a case report of an infant with laryngeal EB requiring tracheostomy. All cases of EB occurring over the past 10 years at The Hospital for Sick Children are reviewed, and the frequency and extent of head and neck involvement, including that of the larynx and trachea, is described. A review of current literature describing laryngeal EB is presented. METHOD: The charts of all patients diagnosed with EB from the period November 1986 to July 1997 were extracted and reviewed in detail. A literature review of reports of laryngeal EB over the past 20 years was completed via a Medline search. RESULTS: Sixteen cases of EB were identified and reviewed. These cases were categorized into the three major subtypes of EB: dystrophic EB, junctional EB, and EB simplex. Three cases of laryngotracheal involvement were reported, one within each subtype. In our literature review, only 18 cases of laryngotracheal EB have been documented in the past 20 years, and most of these were diagnosed with the junctional EB subtype. The overall prognosis for patients with junctional EB based on review of cases in our institution, as well as in our review of literature, was poor. CONCLUSIONS: The extent of EB involvement of the head and neck is variable, often depending on subtype. Laryngeal involvement with EB is very rare but of significance, since mortality within this group of patients is high, with death resulting most often from sepsis.

Catchment Area, Health↗

PubMedDate not supplied

Preventable trauma deaths: evaluation by peer review and a guide for quality improvement. Emergency Medical Study Group for Quality.

BACKGROUND: The trauma-injury severity-score (TRISS) methodology was developed in the United States to calculate the probability of survival for trauma patients presenting for emergency care. OBJECTIVE: We assessed the utility of using the TRISS methodology to identify preventable trauma deaths and compared the results to peer review using explicit standards. METHODS: Explicit peer review standards were developed by a focus group. The validity of these standards was evaluated by comparing the results of peer review performed by two independent expert panels. All trauma cases admitted to 10 centers in Japan between April 1, 1994, and March 31, 1996, were evaluated using the TRISS methodology. Cases with an expected probability of survival of more than 0.5 were considered preventable. These cases were subjected to peer review. Patients who were dead on arrival were excluded from analysis. RESULTS: Of 3,125 patients who were not dead on arrival, the TRISS methodology identified 2,525 as having a probability of survival greater than 0.5. In this group, 189 patients died; thus, 25.3% of all deaths were considered preventable by the TRISS method. Peer review found that only 11.2% of the deaths were preventable; thus, only 46.6% of preventable deaths identified by TRISS were confirmed by peer review. Agreement between the two expert peer review panels was very good (kappa = 0.62). CONCLUSION: TRISS can be used as a screening tool to identify potentially preventable trauma deaths. Peer review is appropriate to confirm preventability and to identify potential medical errors.

Data Collection↗